跳至主要内容
临床试验/NCT00596856
NCT00596856撤回不适用

Development and Dissemination of Oral Health Risk Assessment and Referral Guidelines - PORRT

University of North Carolina, Chapel Hill0 个研究点开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Referral rate defined as the proportion of children of the target age seen in participating medical practices who receive preventive dental services and are referred to an area dentist.

研究概览

简要总结

Purpose:

  1. Revise the existing oral health risk assessment tool (known as the Encounter Form in the IRB-approved project DENT-1527) and develop accompanying guidelines for its use and distribution.
  2. Evaluate the education intervention to accompany the distribution of the new risk assessment tool - the Priority Oral Health Risk Assessment and Referral Tool - PORRT and guidelines.
  3. Evaluate the extent to which the education intervention affects physicians' screening and referral performance (use of guidelines, appropriateness and quality of referrals).

Participants: Primary care medical and dental providers in North Carolina.

Procedures (methods): UNC will engage in a systematic literature review of dental caries risk and a simulation analysis in order to finalize the design of the PORRT referral tool and its accompanying guidelines. Medical providers will be surveyed statewide regarding their oral health screening practices with children under three years of age, and a randomized controlled trial will be implemented in 75 of these practices to evaluate guideline dissemination and effectiveness. Referral behavior will be evaluated through an analysis of the completed PORRT forms and a record review in dental practices serving as referral sites. Medicaid claims analysis will determine referral effectiveness for the RCT sites compared to the state as a whole.

详细描述

The project "Development and Dissemination of a Priority Oral Health Risk Assessment and Referral Tool - PORRT" is designed as an education and training intervention in medical and dental practices statewide. Various evaluation activities, the purpose of the subcontract, will take place during the four years (see attached timeline). The project will collect data statewide on use of guidelines and changes occurring in medical and dental practices in adopting the guidelines. In addition through a RCT in 75 sites, we will measure the adoption rate of guideline use and the quality and effectiveness of referrals occurring as a result of guideline adoption. This multi-phase project is the logical next step in our work with IMB medical practices throughout the state as it seeks to incorporate dental providers by increasing referrals for those children whose dental care cannot be managed in a medical home. And it seeks to revise through a systematic review of the literature the risk assessment form used by all IMB practices.

The planning phase of the project will focus on the development and refinement of the risk assessment and referral tool (PORRT). This will be accomplished through a systematic review of the literature to provide the scientific evidence for risk factors for ECC, and if sufficient information can be derived from the literature, we will develop a three-state (normal, non-cavitated and cavitated lesions) Markov-model to enable comparisons of ECC incidence rates among children with different risk factors.

A revised PORRT with supporting evidence and guidance on its use will then be pilot tested in five medical practices during year 1 of the project (sites to be selected once the tool is completed). This pilot will be conducted by the OHS. Results from the pilot will be incorporated into the development of a final tool and the accompanying documentation (the guidelines) and used in the implementation of the education intervention in the selected 75 RCT sites. (The education intervention is the responsibility of the OHS.)

Prior to the initiation of the RCT, a statewide baseline survey will be carried out during year 2 with all primary care medical providers who see at least 10 Medicaid patients under three years of age per month. This self-completed, mail survey will assess oral health knowledge regarding infants and toddlers, and the likelihood of adoption of the PORRT instrument in the medical practices. (The questionnaire is not yet developed but will be submitted at a later date for IRB approval along with its accompanying consent form.) Data entry and analysis will take place at UNC and will follow all normal procedures for maintaining confidentiality and protection of human subjects.

The randomized controlled trial will begin during year 2. The education intervention and the dissemination of the PORRT tool and guidelines will occur only in the selected 75 RCT practices. The RCT will compare passive distribution of guidelines by mail to an in-office intervention consisting of guideline distribution combined with educational outreach providing training in guideline use and patient mediated information provided by the risk and referral assessment tool (PORRT). The three-arm trial will consist of 25 medical practices that have never participated in IMB and 25 practices that are currently participating, both of which will receive the guidelines through the mail, and 25 practices currently participating in IMB that will receive the more intense in-office training intervention. We hypothesize that effect measures (guideline implementation, and referral quantity, quality and effectiveness) will be most favorable in those practices with the intense intervention, least favorable in those practices that have not participated in the IMB program and somewhat effective for those practices that are participating in IMB but only receive the passive dissemination of guidelines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Licensed and practicing pediatricians in North Carolina who see at least 10 Medicaid children under 3 years of age per month.

排除标准

  • 未提供

结局指标

主要结局

Referral rate defined as the proportion of children of the target age seen in participating medical practices who receive preventive dental services and are referred to an area dentist.

时间窗: Within 6 months of receipt of preventive dental services from a medical practice.

次要结局

  • Implementation of developed guidelines and risk assessment tool in medical practices and identified barriers to their use.(Pre and post guideline dissemination)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gary Rozier, DDS

Professor of Policy & Management

University of North Carolina, Chapel Hill

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